The American Society for Microbiology (ASM) appreciates the opportunity to submit a statement on the FY 2008 budget proposal for the National Institutes of Health (NIH). The ASM is the largest single life science Society with over 42,000 members, many of whom are engaged in biomedical research, clinical diagnosis and education. The ASM is concerned by the erosion in funding for the National Institutes of Health and for biomedical research that has the potential to yield important, life-saving scientific discoveries. The President’s FY 2008 budget request for NIH will exacerbate the already problematic stress on funding for biomedical research. The proposed $28.6 billion budget request includes $300 million to be transferred to the Global Fund for HIV/AIDS, TB and Malaria, making the net NIH budget $28.3 billion, a reduction of roughly $500 million below the FY 2007 funding level. This decrease in funding below the previous year’s NIH budget clearly falls short of the nearly 4 percent biomedical inflation rate projected for FY 2008. The ASM recommends that at least a 6.7 percent increase be approved instead, to sustain crucial biomedical research and advances against infectious diseases and other debilitating diseases and health threats.

Fiscal support for NIH has steadily eroded since 2003 as appropriations have flattened or even decreased. In the last four years, the NIH budget has not kept pace with inflation in the costs of biomedical research and development; as a result, the agency has lost over 10 percent of its purchasing power. Success rates for NIH grant applications have dropped from about 30 percent in 1998 to about 20 percent. This situation, combined with the accelerating pace of promising research advances that cannot be explored, is harmful to young scientists as well as established investigators who are experiencing difficulty continuing their research activities. The future of the research enterprise and our country’s competitiveness in science and technology are at risk.

The federal government funds one-third of all biomedical research in the United States and the NIH is the largest federal supporter of research and development at US colleges and universities. NIH funding thus has significant impact on academic research and educational activities across the country. Failure to provide sufficient funding for the NIH and its grant recipients ultimately will weaken US productivity in the sciences, with unfortunate consequences to public health, education, economic well-being and global scientific leadership.

Federal funding is essential for continued advancement of basic and applied research and the development of new preventions, therapies and cures for chronic and infectious diseases. The discovery of new knowledge depends on robust federal support for research. NIH funding provides the basis for training a highly skilled workforce that is needed for biotechnology and other technology driven industries. University biomedical research and technology transfer also contribute significantly to state and local economic growth and job creation. If NIH budget increases continue to sink below biomedical research inflation, the nation will risk losing its competitive edge in biomedical research globally. We urge that Congress reverse the trend of diminishing support for scientific research even during this time of constrained resources.

The Success of NIH Research and the Need to Increase Research Support

Newly Emerging and Reemerging infectious diseases:Infectious diseases continue to threaten the health of people in the United States and worldwide. Infectious diseases have become a national security issue because the United States is closely connected to the rest of the world in an age of increasing international travel and commerce. In 2006, public health officials reported the emergence of an old enemy with new power, extensively drug-resistant tuberculosis (XDR-TB) that is virtually untreatable with available antimicrobials. They concluded that patients with XDR-TB are over 50 percent more likely to die during treatment than patients with the previously recognized multidrug-resistant (MDR) form of the tuberculosis bacterium. Surveys of international laboratories (2000-2004) indicate that roughly 20 percent of TB isolates were MDR, of which 10 percent were XDR. To date, 20 countries have reported cases and the World Health Organization (WHO) considers the emerging XDR-TB to be “the highest health priority” in nations affected. Tuberculosis has long been a global health catastrophe, causing 9 million new cases and 2 million deaths annually. For many years, control of tuberculosis has been a top research goal at NIH. The National Institute of Allergy and Infectious Diseases (NIAID) supports over 300 TB related research projects and more than a dozen drug and vaccine candidates are being tested in clinical and preclinical trials and studies. Five new diagnostics are being validated in clinical trials and existing diagnostic platforms are being adapted for use in TB applications, including detection of XDR-TB. However, without sustained funding development of these urgently needed new tools (drugs, vaccines, and diagnostics) will be slowed and important research potentially disrupted.

Genome sequencing:Knowing the DNA sequence of microbial pathogens provides valuable insights into how microbial pathogens evolve and the extent of gene transfer between pathogens. By the end of 2006, ongoing NIAID genome sequencing projects had completed 145 sequences that included bacteria, fungi and protozoan parasites of interest. Nearly 2,000 viruses had also been sequenced. These research advances are revealing new ways to confront infection, including the identification of novel targets for antimicrobials and new approaches to diagnostics and vaccine development. Recently published NIAID-supported research, for example, has sequenced genomes from 54 different samples of the most deadly type of malaria parasite. Carried out at NIAID’s Microbial Sequencing Center, it revealed nearly 47,000 genetic variations and will help elucidate malarial drug resistance and potential vaccines. Prevention is a high-priority focus of NIH biomedical research: Each year, this pathogen causes more than 1 million deaths worldwide and an estimated 350-500 million clinical episodes. Funding is needed to translate the sequences into new therapies and vaccines.

Pandemic influenza and seasonal influenza: NIH supported research is strengthening efforts to combat potentially devastating pandemic influenza, which could result from human-to-human transmission of the H5N1 avian influenza virus. The 60 percent mortality and the confirmation of avian infections in 54 countries force public health officials to take the pandemic threat seriously. Basic research is increasing our understanding of how influenza viruses replicate, interact with their hosts, stimulate immune response and evolve into new strains. These basic research findings form the basis for the design of new antiviral drugs, diagnostics and pre-pandemic vaccines. In December 2006, NIH began the first human trial of a DNA vaccine designed to prevent H5N1 avian influenza infection. Unlike conventional influenza vaccines, DNA-based vaccines contain only portions of viral genetic material and therefore carry no infection-causing capabilities. The new vaccine is the first manufactured at NIAID’s Vaccine Pilot Plant, moving from the research bench to clinical trials in less than six months. NIH research is also improving our ability to respond to seasonal influenza epidemics which cause about 36,000 deaths in the United States and 200,000 hospitalizations. Without sustained NIH funding, however, we will be unable to capitalize on these major advances and protect the public’s health.

HIV/AIDS:A recent study highlights the contributions of basic and applied research on HIV/AIDS, which has led to HIV therapies that have provided nearly 3 million years of extended life to people with AIDS in the US since 1989 and prevented 2,900 infant infections from infected mothers. In February, the first large-scale HIV vaccine trial in South Africa began, NIAID-funded and designed to test efficacy of a vaccine containing copies of only three HIV genes. Since the early 1980s, NIH has invested $30 billion in HIV/AIDS research, contributing to the fact that a person initiating HIV therapy in 2003 could expect to live an estimated 13 years longer than if he or she had been diagnosed in 1988. Despite successes in HIV/AIDS treatment and prevention, in 2006 there were 2.9 million AIDS-related deaths worldwide and about 4.3 million people became newly infected with HIV – adding to the grim global total of 39.5 million living with HIV. Antiretroviral therapies have helped cut US death rates by 80 percent (between 1990 and 2003), but only seven countries have more people living with HIV than the United States (1.2 million in 2005). Continued investment in research is needed for development of new antiretroviral drugs as strains of HIV are developing resistance to existing drugs and the potential of an effective vaccine for HIV is the ultimate answer for disease control and prevention.

RNA interference (RNAi):The 2006 Nobel Prize in medicine – awarded to US scientists for describing the mechanism by which cells suppress genes carried by invading viruses – reminds us that investments in basic research yield real-world products that improve human health and impact the nation’s economy. Scientific success stories like that of the Nobel-winning RNAi work clearly demonstrate the importance of investigator-initiated basic research, as well as the need for continued federal investment in long-term, basic research. Understanding the mechanism of RNA interference has suggested ways to create superior new therapies against such disorders as macular degeneration and respiratory syncytial virus (a common childhood infection). Start-up biotechnology firms and major pharmaceutical companies have quickly invested billions of dollars into RNAi research projects, making this new research specialty one of the leading areas in commercial drug development. The first drug candidates already are entering early human clinical trials, and the federal government has just awarded a $23 million contract to a private company to develop RNAi-based drugs as a defense against bioterrorism.

Cancer: Recent data show that the risk for dying from cancer continues to drop. Advances in cancer prevention, early detection and effective treatments contributed to the decrease in deaths from 2003 to 2004, the most recent mortality data available. Death rates dropped for three major cancer sites in both men and women (breast, prostate and colorectal) and for lung cancer in men. This marked the second consecutive year of decline in actual numbers of cancer deaths in the United States. NIH supports cancer research with detection and treatment potential and newly published results give hope for future successes against cancer. For example, a new gene therapy alters the body’s own immune cells to shrink advanced melanoma, the first time gene therapy has been used successfully to treat cancer. Other cutting-edge research, begun in 2005 as The Cancer Genome Atlas (TCGA) Pilot Project at NIH, is beginning to identify genetic changes underlying the most important and common forms of major cancers, beginning with genomic maps of breast and colorectal cancers that reveal many mutated genes not previously known to play a role in cancer. The multi-institution TCGA program ultimately will study changes in a patient’s genetic sequence over time and then use that information to design highly targeted, individually based interventions. In 2006, a vaccine based on NIH research was approved to prevent cervical cancer caused by the human papillomavirus (HPV) infection, which is the second most common cause of female deaths from cancer worldwide. Unfortunately, without real increases in funding the momentum in these remarkable advances will be slowed.

ASM Recommends at Least a 6.7 Percent Increase for NIH for FY 2008

Neglecting budget needs of the NIH will slow progress in key biomedical research, despite the critically important need to explore new opportunities created by previous investments in cutting-edge NIH research. NIH funding has been projected to fall below R&D inflation estimates until FY 2012, while general inflation and rising costs of research will further exacerbate budget declines. Budget shortfalls for the NIH will seriously undercut the world-class science traditionally supported by the agency, currently the largest federal investor in both basic and applied research in the United States.

The opportunities for substantial return on investment in biomedical research have never been greater. It is essential that the NIH be supported at a level to take fuller advantage of promising areas of basic and clinical research. Past investments in biomedical research clearly have benefited humankind in terms of improved health and understanding of disease processes. We note that Congress authorized an 8 percent increase or $32.8 billion for the NIH in FY 2008, and we are grateful for the addition of $620 million to the NIH’s FY 2007 budget. The ASM urges Congress to increase the NIH budget as close as possible to the authorized level and by at least 6.7 percent for FY 2008. This increase will help NIH recapture ground lost to inflation since 2003 and allow it to seize exciting, new research opportunities to improve human health and well-being.

The ASM thanks Congress for its support of biomedical research and the National Institutes of Health and stands ready to work with Congress to include additional funding for the NIH.